Drug labels

Intensive Age Defying Hydrating Complex SPF 25

HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE · June Jacobs Labs, LLC · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
18f59d9d-1328-d815-e063-6294a90a3801
ID
18f59d9d-1329-d815-e063-6294a90a3801
Effective time
20240521
Version
1
SPL product data elements

Intensive Age Defying Hydrating Complex SPF 25 Homosalate, Octinoxate, Oxybenzone, Avobenzone PANTHENOL ASPALATHUS LINEARIS LEAF PHENOXYETHANOL ARNICA MONTANA FLOWER RICE BRAN HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER PHYTATE SODIUM CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE LYCIUM BARBARUM FRUIT ROSA DAMASCENA FLOWER OIL ALCOHOL OCTINOXATE OCTINOXATE ROSA DAMASCENA FLOWERING TOP POLYOXYL 20 CETOSTEARYL ETHER CAPRYLYL GLYCOL PUNICA GRANATUM SEED OIL ALLANTOIN CARAMEL CAPRYLHYDROXAMIC ACID EDETATE SODIUM .BETA.-CITRONELLOL, (R)- GERANIOL CETOSTEARYL ALCOHOL CHLORELLA VULGARIS AVOBENZONE AVOBENZONE SILICON DIOXIDE SODIUM BENZOATE BENZYL BENZOATE SODIUM HYDROXIDE PUNICA GRANATUM ROOT BARK VITIS VINIFERA SEED SOYBEAN GERM COLLAGEN, SOLUBLE, FISH SKIN WATER LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE GREEN TEA LEAF HOMOSALATE HOMOSALATE OXYBENZONE OXYBENZONE CYCLOMETHICONE 5 GLYCERIN SODIUM LACTATE, L- DATE

Active ingredient
Active ingredients Homosalate 10.0% Octinoxate 7.5% Oxybenzone 5.0% Avobenzone 3.0%
Purpose
Sunscreen
Indications and usage

Uses ■ Helps prevent sunburn ■ If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings
Warnings For external use only
Do not use
Do not use on damaged or broken skin
When using
When using this product keep out of eyes. Rinse with water to remove.
Stop use
Stop use and ask a doctor if rash occurs
Keep out of reach of children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage and administration

Directions ■Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear long sleeve shirts, pants, hats and sunglasses ■ Reapply at least every 2 hours ■ Use a water resistant sunscreen if swimming or sweating ■ Children under 6 months: Ask a doctor

Inactive ingredient

Inactive ingredients Water/Aqua/Eau, Water/ Aqua, Rosa Damascena Extract, Ceteareth-20, Cyclopentasiloxane, Glycerin, Cetearyl Alcohol, Caprylyl Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Carbomer, Punica Granatum Seed Oil, Sodium Lactate, Phoenix Dactylifera (Date) Fruit Extract, Caramel, Caprylhydroxamic Acid, Allantoin, Sodium Hydroxide, Panthenol, Sodium Phytate, Chlorella Vulgaris Extract, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Phenoxyethano, Arnica Montana Flower Extract, Oryza Sativa (Rice) Bran Extract, Glycine Soja (Soybean) Germ Extract, Silica, Leuconostoc/Radish Root Ferment Filtrate, Rosa Damascena Flower Oil, Hydrolyzed Elastin, Soluble Collagen, Alcohol, Camellia Sinensis Leaf Extract, Sodium Benzoate, Tetrasodium EDTA, Benzyl Benzoate, Citronellol, Geraniol.

Other safety information
Other information ■ Protect this product from excessive heat and direct sun
Questions
Questions or comments? Call toll free 1-866-JUNEJACOBS ■ www.JUNEJACOBS.com
Package label principal display panel
IAD CARTON IAD TUBE
Harmonized identifiers (openFDA)
Application number
M020
Brand name
Intensive Age Defying Hydrating Complex SPF 25
Generic name
HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE
Manufacturer name
June Jacobs Labs, LLC
Product NDC
65278-103
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
OCTINOXATE, AVOBENZONE, HOMOSALATE, OXYBENZONE
SPL ID
18f59d9d-1329-d815-e063-6294a90a3801
SPL set ID
18f59d9d-1328-d815-e063-6294a90a3801
Package NDC
65278-103-01, 65278-103-02
Is original packager
true
UNII
4Y5P7MUD51, G63QQF2NOX, V06SV4M95S, 95OOS7VE0Y
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.